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NCT01199588 · ClinicalTrials.gov registry record · Phase 2

A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers

A Phase 2 study of Venous Leg Ulcers, sponsored by OcuNexus Therapeutics.

Completed
Registry status
Phase 2
Development phase
300
Enrollment target
20
Study locations

NCT01199588 is a Phase 2 study of Venous Leg Ulcers that has completed, run by OcuNexus Therapeutics. The registered enrollment target is 300 participants, above the 95-participant average among 4 other Venous Leg Ulcers trials with a reported enrollment target (216% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT01199588, a Phase 2 study of Venous Leg Ulcers, has completed, sponsored by OcuNexus Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
300 participants
Enrollment target
20
Study locations

Study Summary

This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.

Conditions Studied

Interventions

  • DRUG Nexagon® Low Dose
  • DRUG Nexagon® High Dose
  • DRUG Nexagon® Vehicle

Study Locations (20)

Arizona

  • Associated Foot and Ankle Specialists, LLC - Phoenix
  • Aung Foot Health Clinics - Tucson
  • Southern Arizona Limb Salvage Alliance - Tucson

California

  • Bay Area Foot Care - Castro Valley
  • Diabetic Foot & Wound Treatment Center - El Centro
  • Advanced Foot Care and Clinical Research Center - Fresno

Pennsylvania

  • Penn North Center For Advanced Wound Care - Erie
  • Penn North Center For Advanced Wound Care - Kittaning
  • Center For Advanced Wound Care - Wyomissing

Florida

  • Doctor's Research Network - South Miami
  • South Florida Wound Care Group - Tamarac

Illinois

  • Northwestern University Feinberg School of Medicine - Chicago
  • Passavant Area Hospital - Jacksonville

New York

  • St Luke's - Roosevelt Hospital Center Department of Surgery - New York
  • Stonybrook Univeristy Medical Center - New York

Texas

  • UT Southwestern Medical Center - Dallas
  • Saint Paul's Women's Center - Dallas

Nevada

  • Advanced Foot & Ankle Center - Las Vegas

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2011-05
Est. Completion 2013-03
Phase Phase 2

Sponsor

OcuNexus Therapeutics

3 total trials

What the Registry Record Tells You About NCT01199588

The ClinicalTrials.gov registry entry for NCT01199588 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 95-participant average among 4 other Venous Leg Ulcers trials with a reported enrollment target (216% higher). The listed sponsor is OcuNexus Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Venous Leg Ulcers appearing as the primary indexed condition, and to 3 interventions - of which Nexagon® Low Dose is the first listed.

NCT01199588 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Arizona, California, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01199588 about?

NCT01199588 is a clinical study titled "A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers". This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.

What is the current status of trial NCT01199588?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2011-05. Estimated completion is 2013-03.

What conditions does trial NCT01199588 study?

This clinical trial studies the following conditions: Venous Leg Ulcers.

What interventions are being tested in trial NCT01199588?

The interventions under investigation include: Nexagon® Low Dose (DRUG), Nexagon® High Dose (DRUG), Nexagon® Vehicle (DRUG).

Who is sponsoring clinical trial NCT01199588?

This trial is sponsored by OcuNexus Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01199588 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.